Monebo Technologies to Present Clinical Results of Fully-Automated System for Cardiac Safety Trials at Drug Information Association Meeting

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System is designed to accelerate drug development by providing pharmaceutical companies more consistent, accurate, and timely electrocardiogram (ECG) interval measurement results, allowing them to quickly assess a compounds cardiac safety profile.

Monebo Technologies, a leader in the monitoring and interpretation of the electrical activity of the heart, today announced it has been invited to present the findings from a clinical trial utilizing a fully-automated ECG analysis software algorithm designed to quickly and accurately asses the effect a drug has on a patient's heart. The meeting, "Cardiovascular Safety and QT/Arrhythmia Assessment in Drug Development - Optimizing Drug Development," is co-sponsored by the Drug Information Association (DIA), FDA and the Heart Rhythm Society, and occurs April 29 through May 1, 2009 in Bethesda, Maryland.

Vladislav Bukhman, PhD will present the results of a trial that was completed with the aid of a large pharmaceutical company, which assesses the performance of a fully-automated algorithm for the evaluation of ECGs during the drug clinical trial process. The results of the study help to validate an automated approach to these specialized trials. The results also represent a major advancement in the methods to provide comprehensive testing and analysis of drugs, and may open new avenues to broaden the use of the technology in this setting. Additionally, Dr. Bukhman will participate in a panel discussion on the use and implementation of automated ECG analysis techniques in drug development.

Pharmaceutical cardiac safety trials, referred to as Thorough QT Trials (TQT), analyze specific points on a patient's ECG before, during, and after a candidate drug, placebo or control drug are administered. The interval of most interest currently is the QT, because studies have shown that QT prolongation can lead to deadly arrhythmias. Current methods of analyzing ECGs include performing manual and semi-automatic measurements and can be quite time consuming as TQT studies typically generate thousands of ECGs. A fully-automated method reduces analysis time, and allows more data points to be used for analysis, potentially reducing the number of patients needed for a particular study, as well as helping to reduce drug development costs while maintaining high quality.

"We are excited to share these results with the scientific community," said Dale Misczynski, President and CEO of Monebo. "Drug safety continues to be a major concern worldwide, and the application of an automated technology could lead to quicker, more accurate results, providing pharmaceutical companies and regulatory bodies a more efficient way to assess the safety of drugs. Monebo continues to search for ways to provide accurate and timely information to clinicians, and automating the process of ECG analysis in drug trials is an excellent application of our technology platform. We anticipate that over time, this will become the method of choice in the industry."

Monebo Technologies, Inc. is a private company based in Austin, Texas, dedicated to developing technology to monitor and interpret the electrical activity of the heart. The company is focused on providing solutions to allow patients and physicians to manage and reduce problems associated with cardiac disease, and have developed technology for ambulatory cardiac monitoring, home care, and pharmaceutical cardiac safety trials. Monebo's proprietary digital signal processing algorithms, highly developed sensor technology, and wireless communication capabilities provide accurate real-time monitoring information, with increased patient mobility.


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